Kornimate/medical-research-clean huggingface dataset:
a study to evaluate an investigational drug in patients with mixed hyperlipidemia (0653a-071)(completed)

Conditions: Hyperlipidemia; Hypercholesterolemia; Hypertriglyceridemia

Summary: the purpose of this study is to assess the cholesterol lowering effects of an investigational drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).


Eligibility criteria:
inclusion criteria: * men and women 18-79 years of age with high cholesterol and high triglycerides. exclusion criteria: * individuals who do not meet specific cholesterol or triglyceride levels as required by the study.

Keywords: mixed hyperlipidemia
comparison of the effectiveness of two psycho-physical interventions: mindfulness based relapse prevention (mbrp) and unguided meditative relaxation in patients with alcohol use disorder

Conditions: Alcohol Use Disorder (AUD)

Summary: alcohol use disorder (aud) is the second highest preventable cause of death in france. only 3% of patients are prescribed approved drugs for reducing alcohol consumption or maintenance of abstinence. increasing evidence supports the efficacy of psychotherapies such as cognitive and behavioral therapies (cbt) in aud. however, some patients are resistant to cbt and the positive effects of cbt could wane over time, resulting in mid- and long-term relapses. mindfulness practice is increasingly widespread in the united states and its efficacy in various fields appears very promising. the study investigators hypothesize that the mindfulness based relapse prevention (mbrp) program will be more efficient than a relaxation/meditation without guidance control program in aud.


Eligibility criteria:
inclusion criteria: * having a moderate to severe alcohol use disorder according to dsm 5 criteria. * the last drink must have been consumed at most in the last 60 days before the pre-inclusion visit. the patient must have had at least 1 hdd during the last drinking period exclusion criteria: * severe depression (beck depression inventory\> 30) * schizophrenic disorder, * current maniac or hypomaniac episode, * patient with dementia or severe cognitive impairment that would prevent him/her from following the course of a session, as judged by the clinician. * insufficient french understanding to complete the questionnaires * pregnant or breastfeeding woman * absence of social security regimen * other mindfulness-based structured therapies * refusal to sign the written consent. • the patient is under safeguard of justice or state guardianship
dose-response study of probiotic bacteria bb-12 and crl-431 in healthy young adults

Conditions: Cardiovascular Disease; Constipation

Summary: the purpose of the study was to investigate the dose-response effect of increasing doses of bifidobacterium animalis ssp lactis (bb-12) and lactobacillus paracasei ssp paracasei (crl-431) on the immune response, blood lipids, gut microflora, recovery from feces and overall tolerance in healthy young adults.

the study included seventy-one healthy young vounteers, and was designed as a double-blind placebo controlled dose-response trial based on a 2 wk run-in period, a 3 wk intervention and 2 wk wash-out period. the subjects were randomly assigned into 5 groups of 15 subjects each, who were supplemented with 0, 10e8, 10e9, 10e10 or 10e10 cfu/d, respectively, og a mixture of bb-12 and crl-431. blood samples were collected 4 times and fecal samples 3 times. diary reporting bowel habits and weel being was kept for all 7 weeks. there are very few articles concerning the issue dose-response effect of probiotics.the aim of the study was to investigate the dose-response effect of increasing concentrations of probiotics on the immune response, blood lipids, composition of the gut microflora, recovery from feces and the overall tolerance. the hypothesis was that the increasing dose would influence the immunresponse (eg incresae phagocytosis), improve blood lipid profile (eg.lower hdl-cholesterol), would be recovered in increasing concentrations in feces, would change the intestinal microfloraprofile and would be well tolerated even in high doses.

Eligibility criteria:
inclusion criteria: * healthy young individuals exclusion criteria: * gi-disease * colosomi * pregnant or lactating women * allergy * individuals receiving the following medicine: antacid, antibiotics, steroids, medicine with influence the intestinal function.

Keywords: probiotics immune response blood lipids intestinal microflora tolerance
study in pre-manifest huntington's disease of coenzyme q10 (ubiquinone) leading to preventive trials (prequel)

Conditions: Huntington's Disease

Summary: to establish the tolerability of treatment with 600, 1200 or 2400 mg per day of coenzyme q10 in pre-manifest participants carrying the cagn expansion for huntington's disease (hd).

secondary objectives: 1. to assess the change from baseline to 20 weeks on biomarkers of oxidative stress (8ohdg and 8ohrg) and dna repair mechanisms (ogg1) in pre-manifest participants treated with 600, 1200 or 2400 mg per day of coq10. 2. to assess the dose-response relationship between coq10 at dosages of 600, 1200 or 2400 mg per day and 8ohdg/8ohrg and ogg1. 3. to assess the serum levels of coq10 at 600, 1200 or 2400 mg in pre-manifest participants and their relationship to 8ohdg/8ohrg and ogg1. 4. to assess the feasibility of implementing a preventive therapeutic trial in a pre-manifest population. 5. to assess the utility and stability of clinical measures of hd, social relations, behavior and employment in a pre-manifest sample enrolled in a treatment trial.

Eligibility criteria:
inclusion criteria: * participants will be positive for the cagn expansion in the huntingtin gene (\>36 repeats) and be pre-manifest by virtue of scoring 3 or less on diagnostic confidence level (question 17 of the uhdrs) * participants will have received genetic testing prior to enrollment through a standard pre-manifest testing protocol. * 18 years of age or older. * concomitant medications are permitted with the exception of coq10, creatine \> 5g/day and warfarin. exclusion criteria: * history of intolerability to coq10. * coq10 use within 60 days prior to randomization. * unstable medical or psychiatric illness; * substance abuse within one year of the baseline visit. * pregnancy, breastfeeding or lack of reliable contraception in women of childbearing age. * subjects with known allergy to fd\&c #6 yellow food coloring.
nephroprotective measures in critically ill patients with moderate/severe acute kidney injury

Conditions: Acute Kidney Injury

Summary: this study investigates to which extent recommended nephroprotective measures are implemented in critically ill patients with moderate or severe acute kidney injury.

acute kidney injury (aki) is a global problem affecting more than 10% of all hospitalized patients and up to 50% of critically ill patients, with survival related not only to the severity,1 but also to the duration of renal dysfunction.2 recent evidence suggests that two-thirds of patients with aki resolve their renal dysfunction within 3-7 days whereas those in whom renal dysfunctions persist have dramatically reduced survival over the following year.2 persistence of aki is of grave importance in that it increases an individual's risk of developing chronic kidney disease (ckd) which is a major cause of morbidity and mortality. this link between aki and ckd has been established over the last decade3 and specific recommendations for the management of patients with aki have been proposed in order to potentially influence this transition.4 to date, there are no specific pharmacological options for preventing or treating aki, which is why new approaches and intensive efforts are urgently needed to reduce the occurrence of aki. the kidney disease: improving global outcomes (kdigo) clinical practice guidelines recommend implementing a bundle of different supportive measures, which, in theory, should be initiated in all patients with aki in order to prevent disease progression. however, clinical practice and recent studies have shown that the implementation of the kdigo bundle is still not standard clinical practice despite the fact that evidence suggest clear effectiveness in the reduction of aki rates.5-9 poor implementation of nephroprotective measures presents a major missed opportunity to reduce aki-related morbidity and mortality and to improve long-term outcomes. to investigate the extent to which nephroprotective measures are implemented in patients with aki can reduce the occurrence of persistent surgical aki, a multi-center prospective cohort study will be performed.

Eligibility criteria:
inclusion criteria: 1. critically ill patients with moderate or severe aki (kdigo stage 2 / 3) 2. requirement of vasopressors or mechanical ventilation 3. age ≥ 18 years 4. informed consent exclusion criteria: 1. chronic kidney disease (ckd) with a glomerular filtration rate \< 20ml/min 2. chronic dialysis dependency 3. history of renal transplantation 4. permanent ligation of the renal arteries 5. aki immediately following nephrectomy 6. patients requiring permanent administration of nephrotoxic drugs (e.g. immunosuppressive therapy afer liver transplantation) 7. persons with any kind of dependency on the investigator or employed by the sponsor or investigator.

Keywords: acute kidney injury kdigo nephroprotective bundle
safety, tolerability, pharmacokinetics and pharmacodynamics of asc61in subjects with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a phase 1, open-label, multicenter, single-arm, dose escalation study, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of single-agent asc61(an orally bioavailable small-molecule inhibitor of pd-l1) in subjects with advanced solid tumors for whom no standard therapy is available.

except for the first starting dose of 200 mg once daily (qd), a traditional "3 + 3 design" will be followed for dose finding with dose escalation and/or de escalation as appropriate. each subject in each dose cohort will use 2 dose schedules: single dose on day 1 (d1), and repeated doses on daily basis for 28 days starting from day 3. one treatment cycle is 28 days. subjects will be sequentially enrolled in a dose-escalation design to receive asc61 at initial dose of 200 mg qd. subsequent doses of 200 mg twice a day (bid), 300 mg bid, 400 mg bid, and 600 mg bid are planned.

Eligibility criteria:
inclusion criteria: * adults ≥ 18 years of age at the time of screening * histological or cytological diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available, regardless of cancer stage and previous experienced therapies * eastern cooperative oncology group (ecog) performance status of 0 or 1 * at least one measurable lesion, as defined by recist 1.1 exclusion criteria: * known symptomatic brain metastases requiring steroids * known history of another primary solid tumor * subjects discontinued prior therapy with immune checkpoints due to toxicity if previously received therapy with this class of drugs * known history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or evidence of active pneumonia or pneumonitis * gastrointestinal disorders that might affect drug absorption
study of magrolimab combination therapy in patients with head and neck squamous cell carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: the goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of the study drug, magrolimab in combination with other anticancer therapies in patients with head and neck squamous cell carcinoma (hnscc).


Eligibility criteria:
key inclusion criteria: * histologically or cytologically confirmed metastatic or locally recurrent hnscc that is considered incurable by local therapies. safety run-in cohort 1 and phase 2 cohorts 1 * should not have had prior systemic therapy administered in the recurrent or metastatic setting. * eligible primary tumor locations include oropharynx, oral cavity, hypopharynx, and larynx. nasopharynx is not included. * hnscc per protocol specified inclusion criteria regardless of pd-l1 status. safety run-in cohort 2 and phase 2 cohort 3 * histologically or cytologically confirmed locally advanced/mhnscc regardless of pd-l1 status with at least 1 and no more than 2 lines of prior systemic anticancer therapy in the locally advanced/metastatic setting. key exclusion criteria: * active central nervous system (cns) disease (individuals with asymptomatic and stable, treated cns lesions who have been off corticosteroids, radiation, or other cns-directed therapy for at least 4 weeks are not considered active). * history of (noninfectious) pneumonitis that required steroids or current pneumonitis. * progressive disease within 6 months of completion of curatively intended treatment for locally advanced/mhnscc. safety run-in cohort 1, pre-expansion safety run-in cohort for magrolimab + pembrolizumab (if applicable), and phase 2 cohorts 1 and 2 * prior treatment with any of the following: * anti-programmed cell death protein 1 or anti-pd-l1 checkpoint inhibitors. * anti-cytotoxic t-lymphocyte-associated protein 4 checkpoint inhibitors. safety run-in cohort 2 and phase 2 cohort 3 * prior treatment with a taxane. note: other protocol defined inclusion/exclusion criteria may apply.
quantitative assessment of swallowing after radiation (quasar)

Conditions: Head and Neck Cancer; Dysphagia; Oropharyngeal Dysphagia; Oropharynx Cancer; Oropharynx Squamous Cell Carcinoma

Summary: to use novel methods for quantitative analysis of vfss (videofluoroscopic swallow study, also known as modified barium swallow) to study and compare dysphagia in patients treated for head and neck carcinoma with concurrent radiation therapy and chemotherapy (cisplatin) or targeted therapy (cetuximab) vs. immunotherapy (pembrolizumab, nivolumab, or durvalumab). our hypothesis is that pharyngeal constriction will be greater (lower ratio) with concurrent immunotherapy compared to chemotherapy, as measured by the pharyngeal constriction ratio (pcr).

the quasar study will use a prospective, observational, cross sectional design (see schema). hnc patients treated with definitive rt and immunotherapy or chemotherapy (cetuximab or cisplatin) will undergo vfss at 4-6 and 12-24 months post-treatment. patients enrolled prior to 6 months after finishing therapy will undergo a swallow study during the 4-6 month period and the 12-24 month period. patients enrolled after 6 months after finishing therapy will undergo a single swallow study in the 12-24 month period. the primary endpoint of pcr at 12-24 months will be compared between patients treated with immunotherapy versus chemotherapy. all patients with hnc treated with definitive rt and systemic therapy at our institution will be eligible. in particular, we will recruit patients for this study from participants in two ongoing trials investigating the use of concurrent immunotherapy. the keychain trial (clinicaltrials.gov identifier: nct03383094) randomizes patients with locally advanced p16+ hnc undergoing definitive rt to concurrent q3 week cisplatin versus concurrent and adjuvant pembrolizumab. nrg-hn004 (clinicaltrials.gov identifier: nct03258554) is a cooperative group trial that compares hnc patients that are not eligible for cisplatin undergoing definitive radiation therapy to concurrent cetuximab versus durvalumab.

Eligibility criteria:
inclusion criteria: * biopsy-proven, un-resected invasive carcinoma of the head and neck. * treated with definitive rt and concurrent systemic therapy or treated within the past 4-24 months * concurrent systemic therapy with cisplatin, cetuximab or immunotherapy. * age ≥ 18 * able to understand and willing to sign a written informed consent. exclusion criteria: * prior radiotherapy that would result in overlap of planned radiation therapy fields. * prior systemic chemotherapy, unless as part of the coordinated plan of care for the treatment of the carcinoma (e.g., induction/neoadjuvant chemotherapy is allowed) * planned adjuvant (i.e., following definitive chemoradiotherapy) chemotherapy or surgery

Keywords: head and neck cancer oropharyngeal dysphagia radiation therapy immunotherapy videofluoroscopic swallow study modified barium swallow study oropharynx cancer oropharynx squamous cell carcinoma
evaluation of the stress response in bariatric surgery with and without the use of opioids

Conditions: Opioid Use, Unspecified; Bariatric Surgery Candidate

Summary: the goal of this clinical trial is to compare opioid free and opioid based anaesthesia in patients undergoing sleeve gastrectomy. the main questions it aims to answer are: * will the total dose of intraoperative opioid be reduced? * will there be difference in pain scores between groups? participants will be managed with the nociceptive level index algorithm to guide intraoperative analgesia. the opioid free anaesthesia group will be administered the multimix infusion (magnesium sulfate, dexmedetomidine, ketamine). the opioid based anaesthesia group will receive fentanyl as a bolus dose and remifentanil infusion. rescue fentanyl bolused will be injected as appropriate according to nociceptive level (nol) values.

opioid free anaesthesia has attracted the attention of clinicians since the outbreak of the opioid pandemic in the usa. it has been correlated with less intraoperative and postoperative opioid use. the nociceptive level index algorithm allows for intraoperative monitoring of the nociceptive pathways and targeted pain management. furthermore, it is known that morbidly obese patients may benefit from opioid sparing techniques. our aim is to investigate the effect of opioid free versus opioid based anesthesia on postoperative pain in patients undergoing sleeve gastrectomy. in this randomized, double blind clinical trial, patients will be allocated into two groups based on intraoperative pain management. apart from recording postoperative pain scores, blood samples will be collected intraoperatively to evaluate the stress response among the two groups.

Eligibility criteria:
inclusion criteria: * age \>18y and \<75y * morbid obesity confirmed diagnosis * american society of anesthesiologists (asa) ii-iii * elective laparoscopic sleeve gastrectomy surgery * signed informed consent exclusion criteria: * bradycardia, bundle branch block, hypotension, postural hypotension * obstructive sleep apnoea * history of depression * chronic corticosteroid use or intraoperative administration of more than 8mg of prednisolone or equivalent * refusal to participate

Keywords: morbid obesity opioid free anaesthesia nociception level analgesia bariatric surgery
allium extracts on the intestinal microbiota in healthy resident volunteers.

Conditions: Intestinal Bacteria Flora Disturbance

Summary: to evaluate the effect of daily consumption of a combination of garlic and onion extracts on the intestinal microbiota and the production of short chain fatty acids in elderly healthy volunteers living in a residence. likewise, any incident related to health that occurred during that period will be noted.

this study is a continuation of another (c002, registration number nct04647071). the volunteers from study c002 were invited to participate in this new study and, by the end of c002, all gave 2 stool samples. after 4 weeks of washout, the control group volunteers in c002 will begin consuming 1 capsule per day of garlic and onion extract after lunch. the intervention group volunteers in c002 will not consume anything. during 36 weeks any incident related to the health of the volunteers will be noted. likewise, during this time, the volunteers will maintain their lifestyle and eating habits. at 36 weeks, 2 stool samples will be taken from all volunteers.

Eligibility criteria:
inclusion criteria: * men and women aged 65 years or older who participated in study c002. * 2. living in the claret residence for the elderly in granada during the study. * accept being vaccinated for the flu. * freely accepted to participate in the study and sign the informed consent document. * have the consent of the family. exclusion criteria: * having any disease that affects the development and results of the study. * be unable to understand the study and sign voluntarily and freely the informed consent. * have a low expectation of compliance with the study protocol.

Keywords: garlic onion microbiota
clenbuterol to target dux4 in fshd

Conditions: Muscular Dystrophy, Facioscapulohumeral

Summary: the purpose of this study is to determine if clenbuterol is a therapeutic option for fshd by determining the safety and tolerability of the medication at three different dose levels.

clenbuterol is an ema approved drug for copd that three independent patient derived screens identified as suppressing dux4 expression in cultured fshd muscle. prior clinical studies with related beta2-agonists showed some activity in fshd but did not meet their primary endpoint, although the prior studies would likely have been designed differently with current knowledge. target fshd is a 6-month open-label multiple ascending dose study of clenbuterol for safety and tolerability to determine the best dose for a future trial of efficacy. in addition, this study will collect secondary outcome data on muscle function, mri changes (lean muscle volume, fat infiltration, stir-rating) and molecular markers of disease activity (histopathology and pre-determined baskets of dux4-target, inflammation, and ecm genes) at the beginning and end of the study to assess and power their utility as measures of drug activity in a future interventional study of efficacy.

Eligibility criteria:
inclusion criteria: * genetically confirmed diagnosis of fshd type 1 or 2, or have a clinical diagnosis of fshd type 1 with a first degree relative with confirmed mutation * between 18 and 75 years of age * with a clinical severity score between 1 and 4 * able to walk 30ft without support of another person * showing anti-gravity strength on at least one of the tibialis anterior muscles or having an mri eligible muscle in the leg for needle biopsy * willing and able to provide informed consent exclusion criteria: * pregnant or planning to become pregnant during the conduct of the study * have a poorly controlled medical condition * were involved in a study of an experimental agent within 3 months of enrollment * are taking beta-blockers or anabolic agent or potassium wasting diuretics * have any condition or contraindication which would interfere with testing or preclude use of beta-agonist * are taking blood thinners or medications which make a needle muscle biopsy contra-indicated * are taking any medications or therapies with a contraindication to clenbuterol

Keywords: fshd